Real-time continuous glucose monitoring for young adults at risk of DKA

Assessment of the Impact of Real-time Continuous Glucose Monitoring on Glycaemic Control in High-risk Adolescents and Young Adults With Insulin-treated Diabetes

This project will try a Dexcom G6 real-time continuous glucose monitor to see if it helps 18-25-year-olds with insulin-treated diabetes who have poor blood sugar control or recent hospital admissions for high blood sugar.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 25 Years
• Sex: All
• Sponsor: Imperial College London (other)
• Locations: 1 site (London)
• Trial ID: NCT04039763 on ClinicalTrials.gov

What this trial studies

This randomized, controlled crossover pilot enrolls 18-25-year-olds with insulin-treated diabetes who have HbA1c >75 mmol/mol (9%) or a recent DKA/uncontrolled hyperglycaemia admission. Participants are randomized to six months of standard fingerprick self-monitoring or six months wearing the Dexcom G6 RT-CGM, then cross over for the second six months. Clinical outcomes (HbA1c, hospital admissions) are collected and participants may share Dexcom Clarity data with clinicians to guide treatment decisions. Semi-structured interviews with a diabetes specialist psychologist at baseline and after CGM use explore self-management barriers and device acceptability, and the pilot data will inform a larger powered trial.

Who should consider this trial

Good fit: Ideal candidates are 18-25-year-olds with insulin-treated diabetes for more than 12 months who are naive to RT-CGM and have HbA1c >75 mmol/mol (9%) or one or more DKA/uncontrolled hyperglycaemia admissions in the past year.

Not a fit: Patients with advanced kidney disease (eGFR <30 ml/min), pregnancy or breastfeeding, active malignancy investigations, severe visual or manual impairment, or who cannot use smartphone-linked devices may not benefit or be eligible.

Why it matters

Potential benefit: If successful, RT-CGM could lower HbA1c, reduce hospital admissions for high blood sugar, and improve daily self-management for high-risk young adults.

How similar studies have performed: Previous RT-CGM studies in adults and adolescents have shown improved glycaemic control and reduced hypoglycaemia, but evidence specifically targeting high-risk young adults with recent DKA is limited.

Eligibility criteria

Inclusion Criteria:

* Adolescents and young adults aged 18-25 years
* Insulin-treated diabetes \>12 months (on multiple daily injections or insulin pump therapy)
* HbA1c \> 75 mmol/mol (9%) or 1 or more DKA admissions in the last 12 months or 1 or more admissions with uncontrolled blood glucose levels in the last 12 months.
* Naïve to RT-CGM - except for short periods for use for diagnosis or monitoring purposes.
* Use of prior flash glucose monitoring is permittable

Exclusion Criteria:

* Chronic kidney disease eGFR \<30ml/min
* Pregnant or planning pregnancy
* Breastfeeding
* Have active malignancy or under investigation for malignancy
* Severe visual impairment
* Reduced manual dexterity
* Unable to participate due to other factors, as assessed by the Chief Investigator

Where this trial is running

London

• Imperial College Clinical Research Facility — London, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Shivani Misra — Imperial College Healthcare NHS Trust
• Study coordinator: Shivani Misra

Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Disease, Autoimmune Diseases, Endocrine System Diseases, Type 1 Diabetes Mellitus